GenSight Biologics announces topline results from
REVERSE Phase III clinical trial of GS010 in patients with Leber Hereditary Optic Neuropathy (LHON)
Paris, France, April 3, 2018, 5.35 pm CET — GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA - PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced topline results from
the REVERSE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in 37 subjects whose visual loss due to 11778 - ND4 Leber Hereditary Optic Neuropathy (LHON) commenced between 6 and 12 months prior to study treatment.
Not exact matches
RESCUE and
REVERSE are two separate randomized, double - masked, sham - controlled pivotal
Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.
GS010 is currently being investigated in two additional ongoing
Phase III trials, RESCUE and REFLECT, while patients in
REVERSE continue to be followed for another 4 years.